Sherlock 3CG™ Tip Confirmation System
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P-wave is intermittent
These conditions may be a result of heart rhythm abnormalities, atrial fibrillation, atrial flutter,
severe tachycardia or presence of cardiac rhythm devices. In these cases, rely on magnetic
navigation and external measurement for tip positioning and use chest x-ray or fluoroscopy to
confirm catheter tip location, as indicated by institutional guidelines and clinical judgment.
Warning:
Do not rely on ECG signal detection for catheter tip positioning when there are no observable
changes in the intravascular P-wave. In this case, rely on magnetic navigation and external measurement
for tip positioning and use chest X-ray or fluoroscopy to confirm catheter tip location, as indicated by
institutional guidelines and clinical judgment.
Warning:
Do not place and/or use the Sherlock 3CG™ TCS in the presence of strong magnetic fields such
as Magnetic Resonance Imaging (MRI) devices. The high magnetic fields created by an MRI device will
attract the equipment with a force sufficient to cause death or serious injury to persons between the
equipment and the MRI device. This magnetic attraction may also damage the equipment. The magnetic
and the RF fields associated with the MRI environment may interfere with the display of ECG
waveforms. Consult the MRI manufacturer for more information.
Warning:
The Sherlock 3CG™ TCS must only be charged with the Medical Grade Power Supply.
Warning:
Do not remove Sherlock 3CG™ TCS enclosures. To avoid electrical shock, use only the power
cord supplied with the system and connect it only to properly grounded wall outlets. Only Bard Access
Systems qualified personnel should service the system.
Warning:
Ensure all connecting cables and connections are electrically insulated and do not come into
contact with other electrical cables or metal surfaces.
Warning:
Ensure that the patient does not directly or indirectly contact non-insulated metal surfaces.
Warning:
Place skin electrodes carefully at locations indicated in these Instructions for Use and ensure
good skin-electrode contact. Failure to do so may cause unstable ECG waveforms and/or ECG
waveforms that are not described in these Instructions for Use. In such a case, rely on magnetic
navigation and external measurement for tip positioning and use chest X-ray or fluoroscopy to confirm
catheter tip location, as indicated by the institutional guidelines and clinical judgment.